Trial Outcomes & Findings for A Study to Evaluate the Effectiveness of Juvéderm® VOLIFT™ With Lidocaine for Lip Augmentation (NCT NCT03796728)

Last Updated: 2021-07-28

Results Overview

The LFS2 is an Investigator assessment of overall lip fullness measured by a 5-point scale where: 0=Minimal (Flat or nearly flat contour; minimal red lip show), 1=Mild (Some red lip show; no lower lip pout), 2=Moderate (Moderate red lip show with slight lower lip pout), 3=Marked (Significant red lip show and lower lip pout), and 4=Very Marked (Very significant red lip show, lower lip pout, and upper lip pout). The percentage of participants with a ≥ 1-point Improvement (Increase) in the Lip Fullness Scale (LFS2) compared to Baseline are reported.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

Baseline (Prior to Treatment) to Day 30

Results posted on

2021-07-28

Participant Flow

Participant milestones

Participant milestones
Measure	Juvéderm® VOLIFT™ With Lidocaine Initial treatment with Juvéderm® VOLIFT™ with Lidocaine injectable gel to augment the lips on Day 1, with an optional touch-up treatment 14 days later, if applicable. Volume was determined by the Investigator not to exceed 3.0 milliliters (mL).
Overall Study STARTED	60
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	24

Reasons for withdrawal

Reasons for withdrawal
Measure	Juvéderm® VOLIFT™ With Lidocaine Initial treatment with Juvéderm® VOLIFT™ with Lidocaine injectable gel to augment the lips on Day 1, with an optional touch-up treatment 14 days later, if applicable. Volume was determined by the Investigator not to exceed 3.0 milliliters (mL).
Overall Study Lost to Follow-up	8
Overall Study Reason not Specified	16

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Juvéderm® VOLIFT™ With Lidocaine n=60 Participants Initial treatment with Juvéderm® VOLIFT™ with Lidocaine injectable gel to augment the lips on Day 1, with an optional touch-up treatment 14 days later, if applicable. Volume was determined by the Investigator not to exceed 3.0 milliliters (mL).
Age, Continuous	36.8 years STANDARD_DEVIATION 9.25 • n=60 Participants
Sex: Female, Male Female	59 Participants n=60 Participants
Sex: Female, Male Male	1 Participants n=60 Participants

PRIMARY outcome

Timeframe: Baseline (Prior to Treatment) to Day 30

Population: Evaluable Set included all participants in the Full Analysis Set who had at least a Baseline and a Day 30 post-treatment efficacy assessment during the study.

Outcome measures

Outcome measures
Measure	Juvéderm® VOLIFT™ With Lidocaine n=59 Participants Initial treatment with Juvéderm® VOLIFT™ with Lidocaine injectable gel to augment the lips on Day 1, with an optional touch-up treatment 14 days later, if applicable. Volume was determined by the Investigator not to exceed 3.0 milliliters (mL).
Percentage of Participants With a ≥ 1-point Improvement (Increase) in the Lip Fullness Scale (LFS2) Compared to Baseline Assessment at Day 30	93.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Prior to Treatment) to Day 30, Months 3, 6, and 12

Population: Evaluable Set included all participants in the Full Analysis Set who had at least a Baseline and a Day 30 post-treatment efficacy assessment during the study. Number analyzed is the number of participants with available data for analysis at the given timepoint

The Investigator assessed the participant's oral commissures lines (lines at the corner of the mouth) using the OCSS 4 point scale where: 0=None (No wrinkle or fold; slight upturned corners), 1=Mild (Shallow, just perceptible wrinkle or crease; horizontal or slightly downturned corners), 2=Moderate (Moderately deep and/or long wrinkle or crease; downturned corners), and 3=Severe (Very deep and/or long wrinkle or crease; frown at rest). A negative change from Baseline indicates improvement. A positive change from Baseline indicates a worsening. The number of participants is reported for each of the following point changes from Baseline: -3 to 3 at each timepoint.

Outcome measures

Outcome measures
Measure	Juvéderm® VOLIFT™ With Lidocaine n=59 Participants Initial treatment with Juvéderm® VOLIFT™ with Lidocaine injectable gel to augment the lips on Day 1, with an optional touch-up treatment 14 days later, if applicable. Volume was determined by the Investigator not to exceed 3.0 milliliters (mL).
Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) Change from Baseline to Month 3 · -2 Point Change	4 Participants
Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) Change from Baseline to Month 12 · 3 Point Change	0 Participants
Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) Change from Baseline to Day 30 · -3 Point Change	0 Participants
Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) Change from Baseline to Day 30 · -2 Point Change	5 Participants
Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) Change from Baseline to Day 30 · -1 Point Change	29 Participants
Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) Change from Baseline to Day 30 · 0 Point Change (No change)	25 Participants
Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) Change from Baseline to Day 30 · 1 Point Change	0 Participants
Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) Change from Baseline to Day 30 · 2 Point Change	0 Participants
Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) Change from Baseline to Day 30 · 3 Point Change	0 Participants
Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) Change from Baseline to Month 3 · -3 Point Change	0 Participants
Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) Change from Baseline to Month 3 · -1 Point Change	27 Participants
Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) Change from Baseline to Month 3 · 0 Point Change (No change)	21 Participants
Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) Change from Baseline to Month 3 · 1 Point Change	0 Participants
Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) Change from Baseline to Month 3 · 2 Point Change	0 Participants
Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) Change from Baseline to Month 3 · 3 Point Change	0 Participants
Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) Change from Baseline to Month 6 · -3 Point Change	1 Participants
Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) Change from Baseline to Month 6 · -2 Point Change	3 Participants
Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) Change from Baseline to Month 6 · -1 Point Change	22 Participants
Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) Change from Baseline to Month 6 · 0 Point Change (No change)	21 Participants
Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) Change from Baseline to Month 6 · 1 Point Change	4 Participants
Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) Change from Baseline to Month 6 · 2 Point Change	0 Participants
Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) Change from Baseline to Month 6 · 3 Point Change	0 Participants
Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) Change from Baseline to Month 12 · -3 Point Change	0 Participants
Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) Change from Baseline to Month 12 · -2 Point Change	3 Participants
Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) Change from Baseline to Month 12 · -1 Point Change	9 Participants
Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) Change from Baseline to Month 12 · 0 Point Change (No change)	22 Participants
Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) Change from Baseline to Month 12 · 1 Point Change	2 Participants
Number of Participants With Change From Baseline in the Investigator's Assessment of Oral Commissures Lines as Measured by the 4-point Oral Commissures Severity Scale (OCSS) Change from Baseline to Month 12 · 2 Point Change	0 Participants

SECONDARY outcome

Timeframe: Baseline (Prior to Treatment) to Day 30, Months 3, 6, and 12

The FACE-Q™ is a validated 10 question assessment measuring how satisfied the participant is with their lips. Each question is answered on a 4-point scale where: 1=Very Dissatisfied, 2=Somewhat dissatisfied, 3=Somewhat satisfied, and 4= Very Satisfied. The responses to the items were converted to a 100-point Rausch transformed scale score: 0 (worst) to 100 (best). Higher scores indicate higher satisfaction. A positive change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Juvéderm® VOLIFT™ With Lidocaine n=59 Participants Initial treatment with Juvéderm® VOLIFT™ with Lidocaine injectable gel to augment the lips on Day 1, with an optional touch-up treatment 14 days later, if applicable. Volume was determined by the Investigator not to exceed 3.0 milliliters (mL).
Change From Baseline in Participant's Assessment of Overall Satisfaction With Lips as Measured by the FACE-Q Lips Questionnaire Change from Baseline to Day 30	45.2 score on a scale Standard Deviation 27.16
Change From Baseline in Participant's Assessment of Overall Satisfaction With Lips as Measured by the FACE-Q Lips Questionnaire Change from Baseline to Month 3	42.7 score on a scale Standard Deviation 30.23
Change From Baseline in Participant's Assessment of Overall Satisfaction With Lips as Measured by the FACE-Q Lips Questionnaire Change from Baseline to Month 6	38.5 score on a scale Standard Deviation 26.25
Change From Baseline in Participant's Assessment of Overall Satisfaction With Lips as Measured by the FACE-Q Lips Questionnaire Change from Baseline to Month 12	23.6 score on a scale Standard Deviation 31.78

SECONDARY outcome

Timeframe: Day 30, Months 3, 6, and 12

The Investigator assessed the participant's global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1=Improved, 0=No Change, -1= Worse, and -2=Much Worse. The number of participants in each score response category at each timepoint is reported.

Outcome measures

Outcome measures
Measure	Juvéderm® VOLIFT™ With Lidocaine n=59 Participants Initial treatment with Juvéderm® VOLIFT™ with Lidocaine injectable gel to augment the lips on Day 1, with an optional touch-up treatment 14 days later, if applicable. Volume was determined by the Investigator not to exceed 3.0 milliliters (mL).
Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) Month 6 · -1=Worse	0 Participants
Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) Month 6 · -2=Much Worse	0 Participants
Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) Day 30 · 2=Much Improved	32 Participants
Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) Day 30 · 1=Improved	27 Participants
Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) Day 30 · 0=No Change	0 Participants
Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) Day 30 · -1=Worse	0 Participants
Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) Day 30 · -2=Much Worse	0 Participants
Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) Month 3 · 2=Much Improved	24 Participants
Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) Month 3 · 1=Improved	28 Participants
Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) Month 3 · 0=No Change	0 Participants
Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) Month 3 · -1=Worse	0 Participants
Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) Month 3 · -2=Much Worse	0 Participants
Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) Month 6 · 2=Much Improved	12 Participants
Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) Month 6 · 1=Improved	39 Participants
Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) Month 6 · 0=No Change	0 Participants
Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) Month 12 · 2=Much Improved	2 Participants
Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) Month 12 · 1=Improved	28 Participants
Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) Month 12 · 0=No Change	6 Participants
Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) Month 12 · -1=Worse	0 Participants
Number of Participants by Investigator's Assessment of Global Aesthetic Improvement Score Category as Measured by the 5-point Global Aesthetic Improvement Scale (GAIS) Month 12 · -2=Much Worse	0 Participants

SECONDARY outcome

Timeframe: Day 30, Months 3, 6, and 12

The participant assessed their global aesthetic improvement using the GAIS 5-point scale where: 2=Much Improved, 1= Improved, 0=No Change, -1=Worse, -2=Much Worse. The number of participants in each score response category at each timepoint is reported.

Outcome measures

Outcome measures
Measure	Juvéderm® VOLIFT™ With Lidocaine n=59 Participants Initial treatment with Juvéderm® VOLIFT™ with Lidocaine injectable gel to augment the lips on Day 1, with an optional touch-up treatment 14 days later, if applicable. Volume was determined by the Investigator not to exceed 3.0 milliliters (mL).
Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS Day 30 · -2=Much Worse	0 Participants
Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS Month 3 · 2=Much Improved	28 Participants
Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS Month 3 · 1=Improved	21 Participants
Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS Day 30 · 2=Much Improved	32 Participants
Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS Day 30 · 1=Improved	25 Participants
Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS Day 30 · 0=No Change	1 Participants
Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS Day 30 · -1=Worse	1 Participants
Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS Month 3 · 0=No Change	3 Participants
Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS Month 3 · -1=Worse	0 Participants
Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS Month 3 · -2=Much Worse	0 Participants
Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS Month 6 · 2=Much Improved	15 Participants
Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS Month 6 · 1=Improved	34 Participants
Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS Month 6 · 0=No Change	2 Participants
Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS Month 6 · -1=Worse	0 Participants
Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS Month 6 · -2=Much Worse	0 Participants
Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS Month 12 · 2=Much Improved	6 Participants
Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS Month 12 · 1=Improved	25 Participants
Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS Month 12 · 0=No Change	5 Participants
Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS Month 12 · -1=Worse	0 Participants
Number of Participants by Participant's Assessment of Global Aesthetic Improvement Score Categories as Measured by the 5-point GAIS Month 12 · -2=Much Worse	0 Participants

SECONDARY outcome

Timeframe: Day 30, Months 3, 6, and 12

The participant assessed the natural look of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported.

Outcome measures

Outcome measures
Measure	Juvéderm® VOLIFT™ With Lidocaine n=59 Participants Initial treatment with Juvéderm® VOLIFT™ with Lidocaine injectable gel to augment the lips on Day 1, with an optional touch-up treatment 14 days later, if applicable. Volume was determined by the Investigator not to exceed 3.0 milliliters (mL).
Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale Day 30 · 1	0 Participants
Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale Day 30 · 2=Somewhat	3 Participants
Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale Month 12 · 0=Not at all	0 Participants
Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale Month 12 · 1	0 Participants
Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale Month 12 · 2=Somewhat	4 Participants
Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale Month 12 · 3	5 Participants
Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale Month 12 · 4=Very much	26 Participants
Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale Month 12 · Missing	1 Participants
Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale Day 30 · 0=Not at all	0 Participants
Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale Day 30 · 3	18 Participants
Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale Day 30 · 4=Very much	38 Participants
Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale Day 30 · Missing	0 Participants
Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale Month 3 · 0=Not at all	0 Participants
Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale Month 3 · 1	0 Participants
Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale Month 3 · 2=Somewhat	0 Participants
Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale Month 3 · 3	15 Participants
Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale Month 3 · 4=Very much	37 Participants
Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale Month 3 · Missing	0 Participants
Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale Month 6 · 0=Not at all	0 Participants
Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale Month 6 · 1	0 Participants
Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale Month 6 · 2=Somewhat	1 Participants
Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale Month 6 · 3	20 Participants
Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale Month 6 · 4=Very much	30 Participants
Number of Participants by Assessment of Natural Look of Their Lips Score Category as Measured by a 5-point Likert Scale Month 6 · Missing	0 Participants

SECONDARY outcome

Timeframe: Day 30, Months 3, 6, and 12

The participant assessed the natural feel of their lips using a 5-point Likert scale where: 0=Not at All to 4=Very Much. The number of participants in each score response category at each timepoint is reported.

Outcome measures

Outcome measures
Measure	Juvéderm® VOLIFT™ With Lidocaine n=59 Participants Initial treatment with Juvéderm® VOLIFT™ with Lidocaine injectable gel to augment the lips on Day 1, with an optional touch-up treatment 14 days later, if applicable. Volume was determined by the Investigator not to exceed 3.0 milliliters (mL).
Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale Day 30 · 0=Not at all	1 Participants
Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale Day 30 · 1	0 Participants
Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale Day 30 · 2=Somewhat	5 Participants
Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale Month 6 · 4=Very much	28 Participants
Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale Month 12 · 0=Not at all	0 Participants
Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale Month 12 · 1	0 Participants
Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale Month 12 · 2=Somewhat	4 Participants
Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale Month 12 · 3	4 Participants
Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale Day 30 · 3	21 Participants
Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale Day 30 · 4=Very much	32 Participants
Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale Month 3 · 0=Not at all	0 Participants
Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale Month 3 · 1	0 Participants
Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale Month 3 · 2=Somewhat	1 Participants
Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale Month 3 · 3	17 Participants
Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale Month 3 · 4=Very much	34 Participants
Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale Month 6 · 0=Not at all	0 Participants
Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale Month 6 · 1	0 Participants
Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale Month 6 · 2=Somewhat	2 Participants
Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale Month 6 · 3	21 Participants
Number of Participants by Assessment of Natural Feel of Their Lips Score Category as Measured by a 5-point Likert Scale Month 12 · 4=Very much	28 Participants

SECONDARY outcome

Timeframe: Day 30, Months 3, 6, and 12

The Investigator evaluated the smoothness of product using a 5-point scale where: 0=Lumpy/Grainy, 1=Faintly Smooth, 2=Somewhat Smooth, 3= Smooth, and 4=Very Smooth. The number of participants in each score response category at each timepoint is reported.

Outcome measures

Outcome measures
Measure	Juvéderm® VOLIFT™ With Lidocaine n=59 Participants Initial treatment with Juvéderm® VOLIFT™ with Lidocaine injectable gel to augment the lips on Day 1, with an optional touch-up treatment 14 days later, if applicable. Volume was determined by the Investigator not to exceed 3.0 milliliters (mL).
Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale Day 30 · 1=Faintly Smooth	1 Participants
Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale Day 30 · 2=Somewhat Smooth	1 Participants
Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale Day 30 · 3=Smooth	22 Participants
Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale Month 6 · 3=Smooth	17 Participants
Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale Day 30 · 0=Lumpy/Grainy	0 Participants
Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale Day 30 · 4=Very Smooth	35 Participants
Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale Month 3 · 0=Lumpy/Grainy	0 Participants
Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale Month 3 · 1=Faintly Smooth	0 Participants
Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale Month 3 · 2=Somewhat Smooth	3 Participants
Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale Month 3 · 3=Smooth	14 Participants
Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale Month 3 · 4=Very Smooth	35 Participants
Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale Month 6 · 0=Lumpy/Grainy	0 Participants
Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale Month 6 · 1=Faintly Smooth	0 Participants
Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale Month 6 · 2=Somewhat Smooth	1 Participants
Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale Month 6 · 4=Very Smooth	33 Participants
Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale Month 12 · 0=Lumpy/Grainy	0 Participants
Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale Month 12 · 1=Faintly Smooth	1 Participants
Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale Month 12 · 2=Somewhat Smooth	2 Participants
Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale Month 12 · 3=Smooth	0 Participants
Number of Participants by Investigator's Assessment of Product Smoothness Score Categories as Measured by a 5-point Scale Month 12 · 4=Very Smooth	33 Participants

SECONDARY outcome

Timeframe: Day 30, Months 3, 6, and 12

The investigator evaluated the improvement of the participant's dynamic lip lines upon animation using a 4-point scale where: 0=Worse, 1=No Change, 2=Improved, 3=Much Improved. The number of participants in each score response category at each timepoint is reported.

Outcome measures

Outcome measures
Measure	Juvéderm® VOLIFT™ With Lidocaine n=59 Participants Initial treatment with Juvéderm® VOLIFT™ with Lidocaine injectable gel to augment the lips on Day 1, with an optional touch-up treatment 14 days later, if applicable. Volume was determined by the Investigator not to exceed 3.0 milliliters (mL).
Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories Day 30 · 1=No Change	2 Participants
Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories Day 30 · 2=Improved	30 Participants
Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories Month 3 · 2=Improved	28 Participants
Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories Month 6 · 3=Much Improved	19 Participants
Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories Day 30 · 0=Worse	0 Participants
Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories Day 30 · 3=Much Improved	27 Participants
Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories Month 3 · 0=Worse	0 Participants
Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories Month 3 · 1=No Change	2 Participants
Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories Month 3 · 3=Much Improved	22 Participants
Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories Month 6 · 0=Worse	0 Participants
Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories Month 6 · 1=No Change	6 Participants
Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories Month 6 · 2=Improved	26 Participants
Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories Month 12 · 0=Worse	0 Participants
Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories Month 12 · 1=No Change	10 Participants
Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories Month 12 · 2=Improved	20 Participants
Number of Participants by Investigator's Assessment of Dynamic Lip Lines Upon Animation Score Categories Month 12 · 3=Much Improved	6 Participants

Adverse Events

Juvéderm® VOLIFT™ With Lidocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Therapeutic Area, Head

Allergan

Phone: 714-246-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Publication restrictions are in place

Restriction type: OTHER